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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04276298




Registration number
NCT04276298
Ethics application status
Date submitted
17/02/2020
Date registered
19/02/2020
Date last updated
18/05/2022

Titles & IDs
Public title
Topical Analgesia Post-Haemorrhoidectomy
Scientific title
A Prospective, Multicentre, Double-Blinded Randomised Controlled Trial Comparing Topical Metronidazole, Diltiazem and Lidocaine on Post-Operative Pain Following Excisional Haemorrhoidectomy
Secondary ID [1] 0 0
RCT Haemorrhoidectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhoid Pain 0 0
Hemorrhoids 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metronidazole cream
Treatment: Drugs - Metronidazole and Diltiazem cream
Treatment: Drugs - Metronidazole and Lidocaine cream
Treatment: Drugs - Metronidazole, Diltiazem and Lidocaine cream

Active Comparator: Metronidazole - Group A receiving 10% metronidazole cream

Active Comparator: Metronidazole + Diltiazem - Metronidazole 10% + Diltiazem 2%

Active Comparator: Metronidazole + Lignocaine - Metronidazole 10% + Lignocaine 4%

Active Comparator: Metronidazole + Diltiazem + Lignocaine - Metronidazole 10% + Diltiazem 2% + Lignocaine 4%


Treatment: Drugs: Metronidazole cream
10% metronidazole applied rectally

Treatment: Drugs: Metronidazole and Diltiazem cream
Combination Metronidazole and Diltiazem applied rectally

Treatment: Drugs: Metronidazole and Lidocaine cream
Combination metronidazole and lignocaine applied rectally

Treatment: Drugs: Metronidazole, Diltiazem and Lidocaine cream
Combination of all active agents tested applied rectally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain scores
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Amount of analgesic use
Timepoint [2] 0 0
7 days
Secondary outcome [1] 0 0
Return to work
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Pain on bowel motion: Visual Analog Scale
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Complications
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Re-admission
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Repeat Prescription
Timepoint [5] 0 0
30 days

Eligibility
Key inclusion criteria
- Age =16

- All patients undergoing excisional haemorrhoidectomy
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Age <16,

- history of chronic pain,

- drug allergy or idiosyncracies to any actives or excipients in

- cream,

- breastfeeding,

- any medical history which is a contraindication to any of metronidazole, lidocaine, or
diltiazem including including:

- sick sinus syndrome,

- atrioventricular block,

- hypotension,

- heart failure and bradycardia.

- concomitant medications which are contraindicated to metronidazole, lidocaine or
diltiazem.

- patients already taking diltiazem.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Factorial
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2022
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The
treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely
effective. However, pain following haemorrhoidectomy is known by all to be a miserable
experience and current treatment is not very effective. We have formulated a new cream
treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will
test the effectiveness of the treatments with a multi-centred randomised controlled factorial
trial with four parallel double-blinded arms containing different combinations of the active
agents. The outcomes include pain scores, amount of analgesia required and time to return to
work. The results of our study could provide evidence of an effective treatment for post
haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing
this surgical procedure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04276298
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MBChB, MD, EdD, FRACS, FACS
Address 0 0
Counties Manukau Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04276298